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Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

− Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes − Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO). − Addresses and corrects product and process complaints. − Reports on contract manufacturer performance metrics and ensures management reviews. − Oversees audits of all quality system categories to assess compliance to process excellence standards. − Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management − Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities. − Responsible for supporting the activities of Operations/Engineering/information management in building quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness − Leads and executes upgrades to Quality System − Support QA programs in assuring compliance to the pertinent regulation − Identify and lead cost and technical improvements under the departments’ continuous improvement program. − Provide key inputs and leadership into transformational process developments. − Project Management - provide timely and accurate reporting on project activities. − New Product Introductions & Product Transfers − Lead or actively participate in cross-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely and efficient manner. − Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements.